11+ ISO 13485 Jobs in Pune | ISO 13485 Job openings in Pune

Job Title : Medical Device Engineer

Location : Bangalore / Pune

Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation

Notice Period : Immediate to 1 week

Interview Process : L1-selected candidates will undergo a customer interview

Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.

Key Skills & Knowledge :

• Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
• Experience with FDA and EU MDR regulatory requirements

Responsibilities :

• Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
• Analyze and implement design changes, assess impact, and update documentation accordingly
• Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
• Assess compliance with applicable standards and regulations
• Define CTS/CTQ parameters and actively participate in design reviews
• Follow QMS guidelines and manage changes through PLM.

Job Title: Senior Software engineer / Principal Engineer

Experience range:-8+ Years

Location:- Pune/ Mumbai 

 Experience :

The candidate should have experience with design and development in Java. Experience in multithreading, algorithm, data-structure, database and collection is mandatory.

Requirements:

• Very strong core Java/Spring developer
• Decent experience in implementing observability (monitoring/alerts) for Java apps
• Capable of working with scripting languages.
• Skills Required: Java, Core Java, Data Structures, OOPS, Multithreading, Algorithms, Collection Framework, Java/J2EE, Hibernate, Spring, Spring Boot, Microservices, Restful Services ,SQL

Dear Candidate,

We are urgently looking for a Release- Big data Engineer For Pune Location.

Experience : 5-8 yrs

Location : Pune

Skills: Big data Engineer , Release Engineer ,DevOps, Aws/Azure/GCP Cloud exp. ,

JD:

• Oversee the end-to-end release lifecycle, from planning to post-production monitoring. Coordinate with cross-functional teams (DBA, BizOps, DevOps, DNS).
• Partner with development teams to resolve technical challenges in deployment and automation test runs
• Work with shared services DBA teams for schema-based multi-tenancy designs and smooth migrations.
• Drive automation for batch deployments and DR exercises. YAML based micro service deployment using shell/Python/Go
• Provide oversight for Big Data toolsets for deployment (e.g., Spark, Hive, HBase) in private cloud and public cloud CDP environments
• Ensure high-quality releases with a focus on stability and long-term performance.
• Able to run the automation batch scripts and debug the deployment and functional aspects/ work with dev leads to resolve the release cycle issues.

Regards,

Minakshi Soni

Executive- Talent Acquisition

Rigel Networks

What will I be doing?

As the UX Lead, focused on our Core Experience area, you will define a cohesive strategy and deliver cross-team, multi-phase projects from concept through implementation.

You need to lead an existing team that will be focused on creating a simple, easy-to-use, and best-in-class experience for our users. You'll lead a team of 4-5 product designers not only by means of their product work, and you'll also be a coach and foster their career development

You'll work cohesively with the leadership and engineering team.

Roles and Responsibilities:

• Analyze the product’s present UX pitfalls, optimization, and growth opportunity or the impact of a user problem and then help tune the project scope accordingly with the product partners
• Understand frequency of usage and the relative importance of a feature/experience, and how it fits into the complete product
• Rationally narrow down to a design recommendation with a strong focus on short-term and long-term implications of the choice Independently deliver high-quality visual design work and support the production with the engineering partners
• Write relevant front end code (HTML, CSS)

What Skill do I need? 

• We emphasize proof of work more than your credentials. Lead and support key design projects
• Relevant work experience of 5+years (preferably in a start-up space) 
• Demonstrated experience leading multidisciplinary UX/Product design teams to deliver high-quality projects at scale
• Proficient in Sketch, XD, Photoshop, Illustrator, or other design tools 
• Has experience working in AGILE methodology
• Knowledge of current UX best practices, including user research and accessibility across mobile and web

Selected intern's day-to-day responsibilities include:

1. Working on Photoshop, Illustrator, and Figma

2. Designing infographics, posters, carousels, and journals

3. Create compelling, error-free content aligned with brand guidelines

4. Designing and creating visual assets

5. Assisting in creating graphics, illustrations, and layouts

6. Developing materials for marketing, social media, and websites

7. Staying updated with design trends

8. Researching and referencing before every project

Required Skills:

• Proven work experience as an Enterprise / Data / Analytics Architect - Data Platform in HANA XSA, XS, Data Intelligence and SDI
• Can work on new and existing architecture decision in HANA XSA, XS, Data Intelligence and SDI
• Well versed with data architecture principles, software / web application design, API design, UI / UX capabilities, XSA / Cloud foundry architecture
• In-depth understand of database structure (HANA in-memory) principles.
• In-depth understand of ETL solutions and data integration strategy.
• Excellent knowledge of Software and Application design, API, XSA, and microservices concepts

Roles & Responsibilities:

• Advise and ensure compliance of the defined Data Architecture principle.
• Identifies new technologies update and development tools including new release/upgrade/patch as required. 
• Analyzes technical risks and advises on risk mitigation strategy.
• Advise and ensures compliance to existing and development required data and reporting standard including naming convention.

The time window is ideally AEST (8 am till 5 pm) which means starting at 3:30 am IST. We understand it can be very early for an SME supporting from India. Hence, we can consider the candidates who can support from at least 7 am IST (earlier is possible).

Job Title:  .Net Developer

Experience- 2-4 years

Qualification- BE/BTech/ME/MTech/MCA or equivalent

Location:  Pune

Job Description

.Net Developer

• Designing Web pages in ASP.NET technology
• Coding in C# (Building the application’s Business Logic and other related software code)
• Hands on experience on SQL Server
• NET, C#, .NET framework 3.5 work experience
• Experience in Framework 4.5 / Bootstrap / HTML 5 / JQuery / LINQ to SQL
• Requirement gathering through client interaction
• Understanding of change request processes and other software development processes and preparing technical documentation
• Problem-solving and thinking laterally as part of a team, or individually, to meet the needs of the project
• Doing Manual unit Testing of the software developed
• Experience in Deployment and Build management
• Consulting clients/colleagues concerning the maintenance and performance of software applications and obtaining information, clarify details and implement information